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| Name | Class |
|---|---|
| Samsung SDS Asia Pacific Pte Ltd | UNKNOWN |
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The aim of this study is to compare Holter versus S patch in a group of elderly patients who are referred to the Geriatrics service in Changi General Hospital for falls from Accident and Emergency department, clinic and wards.
The investigator hope to assess the feasibility, adherence and patient acceptability as an alternative to Holter monitoring. The investigator also hope to learn if S-Patch EX monitoring system can be as effective or equivalent to Holter in the monitoring of arrhythmias and the possibility of deploying it for longer term monitoring of arrhythmias.
Participants who consented to be in this study will be offered S patch and Holter consecutively. Holter will be worn for 24 hours and S patch will be worn for 72 hours. The order which Holter or S patch will be worn first will be determined via randomisation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (Holter for 24 hour follow by S Patch3-Cardio/S-Patch Ex for 72 hours) | Active Comparator | Holter for 24 hour follow by S Patch3-Cardio/S-Patch Ex for 72 hours |
|
| Group B (S Patch3-Cardio/S-Patch Ex for 72 hours follow by Holter for 24hour). | Active Comparator | S Patch3-Cardio/S-Patch Ex for 72 hours follow by Holter for 24hour |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S Patch3-Cardio/S-Patch Ex | Device | S Patch3-Cardio/S-Patch Ex for 72 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participant's Compliance | An events diary and questionnaire to evaluate their preference between Holter and the S-Patch recorder. The hours of recording from both devices will also be captured in both devices report. | From date of randomization until the day participant completed both device monitoring, assessed up to 4 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Device sensitivity and specificity | Assess sensitivity and specificity of S Patch3-Cardio/S-Patch Ex compared to Holter to diagnose the bradyarrhythmia/arrhythmia. The sensitivity and specificity will be analyzed from the device report. Outcome comparison between the two treatment arms using McNemars test. | 72 hours for S Patch3-Cardio/S-Patch Ex and 24hours for Holter |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yeo Colin | Changi General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changi General Hospital | Singapore | Singapore | 529889 | Singapore |
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| ID | Term |
|---|---|
| D001919 | Bradycardia |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015716 | Electrocardiography, Ambulatory |
| ID | Term |
|---|---|
| D004562 | Electrocardiography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
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| Holter | Device | Holter for 24 hours |
|
| Durability of the device | Durability of the device in longer term monitoring and in real world situation. The hours of monitoring from S Patch3-Cardio/S-Patch Ex is compare with hours of monitoring from Holter to see if 72 hours of monitoring will have a better outcome compare to only 24hrs of recording. The duration of recording are taken from the device monitoring reports. | 72 hours for S Patch3-Cardio/S-Patch Ex and 24hours for Holter |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
| D018670 | Monitoring, Ambulatory |
| D008991 | Monitoring, Physiologic |